NCT05197712

Evaluation of the Safety, Tolerability, and Reactogenicity of the Baiya SARS-CoV-2 Vax 2 Vaccine for COVID-19 Disease

Status unknown Phase 1 Last updated 24 May 2023

What this trial tests

Phase 1 trial testing 25 Baiya SARS-CoV-2 Vax 2 in COVID-19 Vaccine in 24 participants. Status unknown.

Timeline

28 March 2022

Primary endpoint
29 May 2023

10 April 2024

Quick facts

Lead sponsor	Baiya Phytopharm Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	28 March 2022
Primary completion	29 May 2023
Estimated completion	10 April 2024
Sites	1 location across Thailand

Drugs / interventions tested

• 25 Baiya SARS-CoV-2 Vax 2 — full drug profile →
• 50 Baiya SARS-CoV-2 Vax 2 — full drug profile →

Conditions studied

• COVID-19 Vaccine — all drugs for COVID-19 Vaccine →

Sponsor

Baiya Phytopharm Co., Ltd. — full company profile →

Who can join

Adults 18 to 64, any sex, with COVID-19 Vaccine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigational product Baiya SARS-CoV-2 Vax 2 vaccine is a second-generation of protein subunit vaccine from plant. The primary objective aiming to evaluate the safety, tolerability, and reactogenicity of Baiya SARS-CoV-2 Vax 2 in adults (aged between 18 to 64 years, inclusive) after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart IM, up to 28 days after the second vaccination. The secondary objective aiming to evaluate long-term safety profile (up to 1 year) and evaluate immunogenicity after 2 doses of Baiya SARS-CoV-2 Vax 2 given 21 days apart.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Plant-made vaccines against viral diseases in humans and farm animals.
   Su H, van Eerde A, Rimstad E, Bock R, et al · · 2023 · cited 27× · PMID 37056490 · DOI 10.3389/fpls.2023.1170815
2. Preclinical evaluation of immunogenicity, efficacy and safety of a recombinant plant-based SARS-CoV-2 RBD vaccine formulated with 3M-052-Alum adjuvant.
   Phoolcharoen W, Shanmugaraj B, Khorattanakulchai N, Sunyakumthorn P, et al · · 2023 · cited 15× · PMID 36963999 · DOI 10.1016/j.vaccine.2023.03.027
3. A plant-produced SARS-CoV-2 spike protein elicits heterologous immunity in hamsters.
   Margolin E, Schäfer G, Allen JD, Gers S, et al · · 2023 · cited 14× · PMID 36959936 · DOI 10.3389/fpls.2023.1146234
4. Immunogenicity and efficacy of recombinant subunit SARS-CoV-2 vaccine candidate in the Syrian hamster model.
   Shanmugaraj B, Khorattanakulchai N, Paungpin W, Akkhawattanangkul Y, et al · · 2023 · cited 7× · PMID 36533163 · DOI 10.1016/j.btre.2022.e00779
5. Toward the commercialization of recombinant pharmaceuticals expressed in plants.
   Washida H, Yoshinaka K, Yamada O, Ookawa S, et al · · 2025 · cited 2× · PMID 41257068 · DOI 10.5511/plantbiotechnology.24.1130a
6. Enhancing vaccine effectiveness in the elderly to counter antibiotic resistance: The potential of adjuvants via pattern recognition receptors.
   Jung M, Kim H, Choi E, Shin MK, et al · · 2024 · cited 1× · PMID 39693178 · DOI 10.1080/21645515.2024.2317439
7. Characterization of host cell proteins in the downstream process of plant-Based biologics using LC-MS profiling.
   Panapitakkul C, Bulaon CJI, Pisuttinusart N, Phoolcharoen W. · · 2024 · cited 1× · PMID 39376902 · DOI 10.1016/j.btre.2024.e00856